(Sr) Quality Management Specialist / Qualified Person
About the Opportunity
The main responsibility of the (Senior) Quality Management Specialist / Qualified Person will be to set-up, implement and follow up the implementation and maintenance of the Quality Management System in compliance with requirement of their respective GxP area (GCP/ GMP /GLP) within an R&D area. Additionally, as Qualified Person, you will certify before release for use in clinical trials or export that each batch of investigational medicinal product has been manufactured and checked in accordance with cGMPs and its product specification file.
Based on the level of experience of a candidate, this position could be graded either as a Quality Management Specialist / Qualified Person or a Senior Quality Management Specialist / Qualified Person.
About Ablynx, a Sanofi Company
Ablynx, a Sanofi company, is engaged in the development of Nanobodies®, proprietary therapeutic proteins based on single-domain antibody fragments, which combine the advantages of conventional antibody drugs with some of the features of small-molecule drugs. Nanobodies have potential uses in the treatment of a range of serious and life-threatening human diseases. Ablynx advances a portfolio of Nanobody-based therapeutic programs in several major disease areas, including inflammation, haematology, immuno-oncology and oncology.
- Certify before release for use in clinical trials or export that each batch of investigational medicinal product has been manufactured and checked in accordance with cGMPs and its product specification file;
- Act as a point of contact for queries relating to QP certification and batch release;
- Ensure that all processes and procedures that are required for QP certification I batch release of drug substance are fit for purpose;
- Responsible to set-up and maintain the quality management system in accordance with internal and external international standards and guidelines;
- Responsible for the planning and timely execution of Quality Management process improvements and timely implementation of new or updated procedures;
- Responsible to perform internal audits to verify the compliance of the Ablynx Quality Management System. Guarantee the follow-up of the corrective and preventive actions;
- Responsible to organize and follow-up the required trainings.
To excel in this role you will need to have:
- Industrial Pharmacist registered at the Federal Agency for Medicines and Healthcare Products;
- Authorized to act as a Qualified Person for the release of medicinal products;
- 5 – 10 years of experience in the pharmaceutical and/or Biotechnology industry;
- Experience with document control and Quality management systems;
- Knowledge of health authority's guidelines and regulations regarding GMP and GDP;
- Very good knowledge of English.
What Sanofi can offer you
This is a great opportunity for a Qualified Person who is looking for a role where they can shape the Quality Management processes, develop initiatives and roll-out new processes.
Empower Life Everyday
At Sanofi we work across human health from vaccines to rare diseases, and consumer healthcare. This creates opportunities to work across different areas to build a diverse and exciting career. Sanofi has the capabilities and resources to support your aspirations to fulfill your ambitions and be the best you can be.
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